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NCT ID: NCT05425732 Completed - Clinical trials for Pneumococcal Infection

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

Start date: July 13, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

NCT ID: NCT05425069 Recruiting - Aging Problems Clinical Trials

Evaluation of the EEG Connectivity Using Predominant Dexmedetomidine as Anesthetic in Fragile Brains

BaseDexmed
Start date: January 2, 2022
Phase:
Study type: Observational [Patient Registry]

Elderly brains that present a lower intrinsic cortical activity are very dependent on arousal feeding. In these patients, a strong blockade of afferences generates a synchronic state with a high tendency to sleep. This is done with drugs such as Dexmedetomidine and its indirect effect of inhibiting the amplification of signals and opioids such as remifentanil. Then, by adding a micro-dose of a gabaergic substance to induce loss of consciousness, unconsciousness would be maintained due to the low requirement of a fragile and synchronous brain by a slow continuous injection of an alpha2 agonist. In previous experience, doses of about one-fifth of the usual would be sufficient to maintain unconsciousness (or perhaps disconnected consciousness that could be useful in avoiding excessive depression in slowed integration pathways). These patients also present deficits in the orexinergic response that manifest themselves in greater neuronal inertia and delayed awakening. Gabaergic drugs (propofol and sevoflurane) are especially depressing to orexinergic nuclei. This approach to the elderly brain could have an impact on recovering more easily connectivity of those CNC networks. In elderly patients, one aspect that could control the phenomena of altered connectivity and its impact in developing delirium is the limitation of connection with the environment before the capacity of integration of cortical information has been completely recovered. To analyze frontoparietal connectivity, front frontal coherence, phase lag index, or similar it is necessary to a multichannel EEG (e.g. 10 channels). Otherwise, the frontal EEG from the SEDline monitor device allowed to analyze only spectral characteristics (power, peak frequency, etc.) and correlate them with clinical observations (MoCA).

NCT ID: NCT05424536 Recruiting - Clinical trials for Osteoporotic Fractures

Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical Measurement

BDATChile
Start date: July 18, 2022
Phase:
Study type: Observational [Patient Registry]

Osteoporosis is a skeletal disease leading to bone fragility and increasing the risk of fractures and still remains a major public health problem worldwide. Therefore it is crucial to prevent severe fractures responsible for excess of mortality and considerable morbidity. Patient at risk of fractures are currently identified as having osteoporosis using Dual-energy X-ray Absorptiometry (DXA), assessing the areal or projected Bone Mineral Density (aBMD g.cm-2). In Chile, the hip fracture occurrence is very similar to the international incidence. Due to the demographic and epidemiological transition, the number of hip fracture for patient older than 50 year, is expected to severely increase from about 6.500 (2007) to 30.000 (2050) without adequate preventive and / or therapeutic measures. Even if DXA remains the current gold standard, it is limited by the difficulty to set a threshold in the BMD distribution for osteoporosis diagnosis. Moreover, some medical conditions (chronic kidney disease, diabetes) or drugs (glucocorticoids) are associated with an increase of fracture risk without a BMD decrease. Quantitative ultrasound (QUS) have the advantages of portability, low cost, absence of radiation and need for a radiographic technologist or designated room, and are sensitive to both elasticity and geometry of the medium explored by the waves. Among QUS techniques, axial transmission (AT) is a technique for which transducers are aligned along the bone axis. Measured ultrasonic guided waves, associated with an appropriate waveguide model have the potential to yield estimates of material and/or geometrical cortical properties. In vivo combined estimation of both cortical thickness and porosity has been proposed using bidirectional axial transmission (BDAT). BDAT measurement has been recently validated on ex vivo specimen (radius and tibia) and has been tested in a pilot clinical study, in which cortical porosity measured at the one-third distal radius has been found as discriminant of low trauma fractures as DXA. Cortical porosity is increasingly recognized as a major contributor to bone fragility. The hypothesis underlying this project are that (1) it is possible to obtain robust and accurate estimates of cortical thickness and porosity using an improved BDAT device and (2) these estimates are of clinical interest in the context of osteoporosis in elderly. Moreover, novel parameters obtained from automatic classification tools will be tested.

NCT ID: NCT05421598 Active, not recruiting - Asthma Clinical Trials

Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

TIDE-asthma
Start date: June 30, 2022
Phase: Phase 2
Study type: Interventional

This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: - The study duration (per participant) will be up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. - The randomized treatment duration will be up to approximately 60 weeks. - The scheduled number of visits will be 13.

NCT ID: NCT05419375 Recruiting - Solid Tumors Clinical Trials

Screening Study for Participants With Malignant Tumors

Start date: July 22, 2022
Phase: Phase 2
Study type: Interventional

The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.

NCT ID: NCT05416788 Completed - Bruxism Clinical Trials

Effect of Cervical Manipulation on Mouth Opening

Start date: May 11, 2022
Phase: N/A
Study type: Interventional

Objectives: To compare the effects of cervical manipulation on the ranges of motion of mouth opening and painful pressure points in the masseter and temporal muscles after of cervical manipulation compared to the control group. Material and methods: Single-blind randomized clinical trial with two arms, one group intervention and a control group. Hypothesis: There is a significant difference in mouth opening and painful pressure points between the intervention group and the control group. Expected results: The intervention group would significantly increase their mouth opening maximal and decrease pressure pain in the masseter and temporalis muscles.

NCT ID: NCT05415215 Active, not recruiting - Clinical trials for Locally Advanced Breast Cancer

A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer

ProHer
Start date: July 5, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

NCT ID: NCT05408442 Recruiting - Clinical trials for Mechanical Ventilation

Role of Pulmonary Perfusion on Tolerance to Supine Position in Patients With ARDS

Start date: July 1, 2021
Phase:
Study type: Observational [Patient Registry]

The relationship between the presence or absence of endothelial dysfunction and changes in pulmonary perfusion will be evaluated, to then determine if there is any association between changes in the V / Q ratio and tolerance to the supine position after a prone cycle in patients with acute respiratory distress syndrome on mechanical ventilation.

NCT ID: NCT05405166 Active, not recruiting - Clinical trials for Plasma Cell Myeloma Recurrent

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

IRAKLIA
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

NCT ID: NCT05403996 Active, not recruiting - Health Behavior Clinical Trials

Effects of an Active Break Program at Primary School

Activa-Mente
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effectiveness of an active break program at school on physical activity levels and enjoyment, and on-task behavior in children.